PORTLAND, Ore., Jan. 31, 2026 — Trace Biosciences, Inc., a clinical – stage biotechnology firm that develops nerve – targeted imaging agents, announced today that the U.S. Food and Drug Administration (FDA) has given approval to its Investigational New Drug (IND) application for LGW16 – 03, the company’s first nerve – specific fluorescent imaging agent. The IND clearance allows Trace to start first – in – human clinical studies to assess the safety and intraoperative performance of LGW16 – 03 in surgical settings.

LGW16 – 03 is engineered to selectively bind to peripheral nerves and emit a near – infrared fluorescent signal. This enables surgeons to visualize critical nerve structures in real – time during surgery, even when the nerves are buried beneath tissues. Accidental nerve injury continues to be a significant and under – addressed cause of surgical complications in procedures such as prostatectomy, orthopedic surgery, colorectal surgery, and head and neck surgery. These injuries can lead to chronic pain, incontinence, numbness, sexual dysfunction, voice loss, or other permanent loss of function – results that have a profound impact on patients’ quality of life.

“This IND clearance is a major milestone for Trace and validates over a decade of scientific work aimed at making nerves visible to surgeons,” said Connor Barth, Ph.D., Co – Founder and CEO of Trace Biosciences. “Despite the high prevalence and severity of nerve injury, surgeons still lack approved tools to reliably visualize nerves in real – time. We think LGW16 – 03 has the potential to fundamentally enhance surgical safety and patient outcomes.”

Trace plans to start its Phase I clinical study later this year, initially evaluating safety and feasibility in patients undergoing orthopedic surgery. After successful early clinical studies, the company intends to expand development across multiple surgical indications where the risk of nerve injury is high.

“Surgeons usually operate near critical nerves with little to no direct visibility, mainly relying on anatomical knowledge and estimated location,” said Nirmish Singla, MD, MSCS, FACS, a urologic surgeon at Johns Hopkins Medicine and a clinical advisor to Trace. “A real – time nerve imaging agent like LGW16 – 03 could significantly reduce avoidable nerve injuries and change how many common procedures are carried out.”

The IND clearance represents the first clinical program within Trace’s broader nerve – targeted platform, which the company is advancing for applications in fluorescence – guided surgery, nerve repair or stimulation guidance, and diagnostic imaging.

About Trace Biosciences

Trace Biosciences is a clinical – stage biotechnology company that is at the forefront of nerve – targeted imaging technologies for surgery. Founded by leaders in imaging, chemistry, and translational medicine, Trace is developing a new class of small – molecule imaging agents designed to make nerves visible and measurable in clinical settings. The company’s mission is to make safe and precise surgery a reality by making nerves visible in every operating room.

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About LGW16 – 03 (NerveTrace Dx)

LGW16 – 03, also known as NerveTrace Dx, is Trace Biosciences’ leading investigational imaging agent designed to assist surgeons in seeing peripheral nerves in real – time during surgery. The agent selectively highlights nerve tissue using near – infrared fluorescence that can be detected by surgical imaging systems seamlessly integrated into existing surgical workflows. LGW16 – 03 is currently being evaluated in clinical studies under an FDA – cleared Investigational New Drug (IND) application.

Forward – Looking Statements

This press release contains forward – looking statements, including statements about the initiation and timing of clinical trials, potential clinical applications, and expected benefits of Trace Biosciences’ technology. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Trace Biosciences has no obligation to update these statements except as required by law.

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SOURCE Trace Biosciences